IMARA for Black Male Caregivers and Girls Empowerment (IMAGE)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

612 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-05

Study Completion Date

2028-05-31

Brief Summary

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The scientific premise of this research is that individual, interpersonal, and structural factors impact Black girls' sexual reproductive health outcomes (sexually transmitted infection (STI) and Human Immunodeficiency Virus (HIV)) and experience of sexual violence. This study expands STI/HIV prevention programs to include Black male caregivers, a potentially valuable yet underutilized resource to protect Black girls and reduce their exposure to STI/HIV and sexual violence.

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Detailed Description

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Sexually transmitted infections (STIs) continue to be a major public health problem for Black girls in the United States. Each year 1 in 4 Black girls, 14-19 years old acquires an STI, placing them at risk for poor sexual and reproductive health outcomes (SRH) (i.e., pelvic inflammatory disease, infertility, Human Immunodeficiency Virus (HIV)/Acquired Immunodeficiency Syndrome (AIDS)). In Chicago, STI rates are highest among 13- to 29-year-old Black girls, and they represent 56% of new HIV diagnoses compared to other racial groups, making adolescence an exceptionally vulnerable period. These racial disparities require new and innovative strategies to reduce Black girls' negative SRH outcomes. Familial protection is seen as critical to mitigating risk, particularly exposure to sexual violence, which is linked to girls' STI/HIV risk. Interventions that strengthen family relationships and communication as strategies to protect Black girls have demonstrated success in improving Black girls' SRH outcomes. Yet, with few exceptions, these programs engage only female caregivers, whereas male caregivers may amplify the protective effects of families on Black girls' SRH. The investigators systematically adapted IMARA (an evidence-based program designed for Black girls and their female caregivers) to create Informed, Motivated, Aware, and Responsible about AIDS (IMARA) for Black Male caregivers and Girls Empowerment (IMAGE), adding drivers of structural violence (i.e., stereotype messaging and lack of protection) aligning with the Becoming a Sexual Black Woman framework and the Health Disparities Research Framework. Preliminary data (interviews, focus groups, theatre, and pilot testing) with Black girls and male and female caregivers justify the proposed randomized control trial (RCT). The investigators will rigorously evaluate IMAGE's efficacy in a randomized control trial while carefully documenting implementation determinants and processes to inform adoption and sustainability. Aim 1 is to conduct a 2-arm RCT (IMAGE vs. a health promotion control) with 300 14-18-year old Black girls and their male caregivers and compare girls' sexual risk behavior (condom use, sexual debut, and sexual partners) and STI incidence at baseline, 6- and 12-months. The investigators hypothesize that girls in IMAGE will have lower STI incidence at 6- and 12- months (primary outcome) and report more condom use and fewer sexual partners (secondary outcomes) compared to the control group. The investigators will also explore change in the theoretical mechanisms posited by the Becoming a Sexual Black Woman framework. Aim 2 is to identify processes, barriers, and constraints associated with primary outcomes to inform future sustainability in community-based organizations. The long-term significance and impact of this application are high. By including Black male caregivers in the protection of girls, this study leverages a long-neglected yet important resource in Black girls' SRH, thereby amplifying the protective effects of family-based programs and pushing the science of health disparities forward.

Conditions

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Sexually Transmitted Infections (Not HIV or Hepatitis) HIV Infections Sexual Behavior

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study will evaluate the efficacy of IMAGE with 14-18-year-old Black girls (n=300) and male caregivers (n=300) in a 2-arm individually randomized controlled trial. The researchers will compare SRH outcomes (STI incidence, self-reported sexual behavior) at 6- and 12-months among girls randomized to IMAGE or a time-matched general health promotion control program (FUEL).

The researchers will simultaneously evaluate implementation determinants (barriers, facilitators, constraints) and processes at Community Based Organizations working through the 3 steps of the implementation model (Prepare, Roll out, and Sustain).

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Investigators

Study Groups

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Experimental (IMAGE) Group

The IMAGE group will receive an 8-10-hour HIV/STI group-based (6-8 dyads) prevention program delivered to Black male caregivers and girls over 2-days.

Group Type EXPERIMENTAL

IMARA for Black Male Caregivers and Girls Empowerment

Intervention Type BEHAVIORAL

IMAGE is delivered by trained Black female facilitators to improve girls' SRH outcomes, prevention HIV/STIs, and reduce sexual violence. Over the two days, some components of the curriculum are delivered separately to male caregivers and girls, covering parallel content, and other sections are delivered jointly in a single group. The curriculum, extensively tailored for the target population and pilot tested, addresses Black girls' sexual development, risk for sexual violence, female anatomy, body positivity, HIV/STI knowledge and attitudes, and condom use. IMAGE is designed to strengthen bonds and communication between male caregivers and girls by encouraging perspective-taking (i.e., reverse role play) and conflict resolution.

Control (FUEL) Group

The FUEL group will receive a caregiver-adolescent general health promotion program identical in length and intensity to IMAGE.

Group Type ACTIVE_COMPARATOR

Time-matched control program

Intervention Type BEHAVIORAL

FUEL will engage Black male caregivers and girls to promote good nutrition, exercise, and informed consumer behavior. Topics include the impact of media on body image, evaluating nutritional labels to make healthy food choices, eating balanced meals, establishing regular exercise routines, and how families and communities can support healthy behavior. FUEL includes a brief video about HIV/AIDS and other STIs but otherwise does not otherwise address sexual health. Like IMAGE, FUEL is delivered in groups of 6-8 dyads over two workshop days (\~10 hours total) in one weekend. Parts of the curriculum are delivered separately to girls and male caregivers covering parallel content and other components are delivered jointly.

Interventions

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IMARA for Black Male Caregivers and Girls Empowerment

IMAGE is delivered by trained Black female facilitators to improve girls' SRH outcomes, prevention HIV/STIs, and reduce sexual violence. Over the two days, some components of the curriculum are delivered separately to male caregivers and girls, covering parallel content, and other sections are delivered jointly in a single group. The curriculum, extensively tailored for the target population and pilot tested, addresses Black girls' sexual development, risk for sexual violence, female anatomy, body positivity, HIV/STI knowledge and attitudes, and condom use. IMAGE is designed to strengthen bonds and communication between male caregivers and girls by encouraging perspective-taking (i.e., reverse role play) and conflict resolution.

Intervention Type BEHAVIORAL

Time-matched control program

FUEL will engage Black male caregivers and girls to promote good nutrition, exercise, and informed consumer behavior. Topics include the impact of media on body image, evaluating nutritional labels to make healthy food choices, eating balanced meals, establishing regular exercise routines, and how families and communities can support healthy behavior. FUEL includes a brief video about HIV/AIDS and other STIs but otherwise does not otherwise address sexual health. Like IMAGE, FUEL is delivered in groups of 6-8 dyads over two workshop days (\~10 hours total) in one weekend. Parts of the curriculum are delivered separately to girls and male caregivers covering parallel content and other components are delivered jointly.

Intervention Type BEHAVIORAL

Other Intervention Names

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IMAGE FUEL

Eligibility Criteria

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Inclusion Criteria

AIM 1:

* Self-identify as African American, Black, or mixed race with African American or Black
* Speak English
* Males must identify as a current caregiver to girl enrolled in the study

AIM 2: All Community Based Organizations (CBO) directors and IMAGE liaisons will be eligible.

Exclusion Criteria

AIM 1:

* Girl refuses to participate
* Inability to understand the consent/assent process
* Non-English speaking
* Does not self-identify as African American, Black, or mixed race with African American or Black
* If the primary caregiver (female caregiver/mother) does not consent to the girls' participation with the male caregiver the girl chooses, the girl will not be able to participate
* Girls will be excluded if they participated in other phases of the research

AIM 2:

• Inability to understand the consent process, and non-employment at a partnering CBO.

Minimum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes